BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARLINK CONTINU-FLO 3 PORTMANIFOLD 10 DPM NV

    MDR report key: 2032899 · Received March 29, 2011

    Report

    Report Number
    6000001-2011-02325
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Date of Event
    October 1, 2010
    Report Date
    October 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FMG
    PMA / PMN Number
    K932512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A CUSTOMER DID NOT SEND IN AN ACTUAL NOR COMPANION SAMPLE FOR EVALUATION; HOWEVER A SIMILAR PRODUCT WAS SENT IN FOR EVALUATION. DURING THE VISUAL INSPECTION THE REPORTED CONDITION WAS NOT CONFIRMED. A FUNCTIONAL TEST AND PRESSURE TEST AT 8PSI WERE PERFORMED WHERE THE RESULTS WERE SATISFACTORY. THE UNIT WAS EVALUATED FOR HAND PULL TEST WITH SUCCESSFUL RESULTS. THE CAUSE FOR THE UNCONFIRMED CONDITION IS UNKNOWN. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SAMPLE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A SEPARATION ISSUE WITH A CONTINU-FLO SOLUTION SET IN WHICH THERE WAS DIFFICULTY SECURING THE MANIFOLD PORTION OF THE TUBING WHICH CAUSED LEAKAGES IN THE OPERATING ROOM. THE CUSTOMER WAS CONNECTING THIS SET TO A MICRO CLAVE LUER. THE FACILITY IS USING A FIRM PUSH AND TWIST METHOD ALWAYS IN ORDER TO CONNECT. THIS INCIDENT OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION WAS AVAILABLE. THIS IS REPORT 2 OF 5 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARLINK CONTINU-FLO 3 PORTMANIFOLD 10 DPM NV STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCLAVE LUER, UNKNOWN SOLUTION